| CTRI Number |
CTRI/2024/10/075715 [Registered on: 23/10/2024] Trial Registered Prospectively |
| Last Modified On: |
18/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Pretreatment with 6% Hydroxyethyl starch (a colloid used for intraoperative fluid therapy) for reduction of propofol (intravenous inducing agent ) injection pain |
|
Scientific Title of Study
|
Pretreatment with 6% Hydroxyethyl starch for reduction of propofol injection pain : A prospective randomized controlled study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Chongtham Pushpa Chanu |
| Designation |
Post Graduation Student |
| Affiliation |
Gajra Raja Medical College , Gwalior , Madhya Pradesh |
| Address |
Jaya Arogya Hospital , Lashkar , Gwalior , Block C - 7th Floor , Anaesthesiology Department Room no 700
Gwalior
MADHYA PRADESH
474009
India |
| Phone |
7005963740 |
| Fax |
|
| Email |
pushpasege@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Satyendra Singh Yadav |
| Designation |
Associate Professor |
| Affiliation |
Gajra Raja Medical College , Gwalior , Madhya Pradesh |
| Address |
Jaya Arogya Hospital , Lashkar , Gwalior , Block C - 7th Floor , Anaesthesiology Department Room no 704
Gwalior
MADHYA PRADESH
474009
India |
| Phone |
9826284553 |
| Fax |
|
| Email |
drssy_17@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Satyendra Singh Yadav |
| Designation |
Associate Professor |
| Affiliation |
Gajra Raja Medical College , Gwalior , Madhya Pradesh |
| Address |
Jaya Arogya Hospital , Lashkar , Gwalior , Block C - 7th Floor , Anaesthesiology Department Room no 704
Gwalior
MADHYA PRADESH
474009
India |
| Phone |
9826284553 |
| Fax |
|
| Email |
drssy_17@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Gajra Raja Medical College , Veer Savakar Marg , Gwalior , Madhya Pradesh, Pincode- 474009 |
|
|
Primary Sponsor
|
| Name |
Dr Chongtham Pushpa Chanu |
| Address |
Jaya Arogya Hospital Campus , Lashkar , Gwalior , Madhya Pradesh Pin- 474009 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Chongtham Pushpa Chanu |
Jaya Arogya Hospital |
Department of Anaesthesiology , C Block , 7th Floor , OT Complex , Lashkar , Gwalior , Madhya Pradesh 474009
Gwalior
MADHYA PRADESH |
7005963740
pushpasege@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee ( IEC ) GAJRA RAJA MEDICAL COLLEGE, GWALIOR , MP |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
6% Hydroxyethyl starch |
One group of patient will be receiving 100 ml of 6% Hydroxyethyl starch 30 minutes before Propofol injection |
| Comparator Agent |
Normal saline |
One group of patient will be receiving 100 ml of Normal saline 30 minutes before propofol injection |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult patients of ASA status I and II
2. Age between 18-65 years old , of either gender
3. Patientd undergoing elective surgery under general anesthesia |
|
| ExclusionCriteria |
| Details |
1. Emergency surgeries
2. Known history of allergy to Propofol or 6% Hydroxyethyl starch
3. Hypertensive , diabetes , presence of left ventricular dysfunction, elevated serum creatinine
4. Those in whom hand or forearm veins are not accessible |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The preadmininstration of 100 ml of 6% Hydroxyethyl starch 3 to 5 mins before Propofol injection can significantly decrease the incidence of pain on injection with propofol in comparison to normal saline ( 28% VS 53% ) |
The pain on propofol injection will be assessed every 10 seconds before the loss of verbal contact by using a 0-3 Verbal Rating Score |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| There is no significant haemodynamic changes ( Heart rate, SBP, DBP) in both groups |
The haemodynamic parameters will be assessed baseline , before induction and 5 mins after intubation. |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
19/11/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study ’ Pretreatment with 6% Hydroxyethyl starch for reduction of Propofol injection pain : A prospective randomized controlled study ’ will be done at Gajra Raja Medical College , Gwalior , MP on sample size of 120 patients for the time period of 8 months . After fulfilling the eligibility criteria , patients will be randomized in two groups by closed envelope method. Group I will be receiving 100 ml 6% Hydroxyethyl starch 3-5 mins before Propofol injection , Group II will be receiving 100 ml NS 3-5 mins before Propofol injection . Pain on Propofol injection will be assessed every 10 secs by using a 0-3 Verbal Rating Score before the loss of verbal contact. Propofol induction dose , time of loss of verbal response, incidence and severity propofol injection pain in both groups , Haemodynamic parameters such as Heart rate , Systolic blood pressure , Diastolic blood pressure will be observed in both groups. After the study , results will be obtained. Primary aim of this study is to study the effect of 6% Hydroxyethyl starch pretreatment for reduction of pain on propofol injection . This study expects that pre administration of 100 ml of 6% Hydroxyethyl starch 3-5 mins before propofol injection can significantly decrease the pain on injection with propofol in comparison to Normal Saline. |